Contemporary use of balloon aortic valvuloplasty and evaluation of its success in different hemodynamic entities of severe aortic valve stenosis.

OBJECTIVES: To evaluate outcome assessment of percutaneous balloon aortic valvuloplasty (BAV) in different flow and gradient patterns of severe aortic stenosis (AS). BACKGROUND: The mean pressure gradient reduction after BAV is an often-used surrogate parameter to evaluate procedural success. The definition of a successful BAV has not been evaluated in different subgroups of severe AS, which were introduced in the latest guidelines on the management of patients with valvular heart disease. METHODS: In this observational study, consecutive patients from July 2009 to March 2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG), and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic, and clinical information were collected and compared. RESULTS: One-hundred-fifty-six patients were grouped into NFHG (n = 68, 43.5%), LFLG (n = 68, 43.5%), and pLFLG (n = 20, 12.8%) AS. Mean age of the study population was 81 years. Cardiogenic shock or refractory heart failure (46.8%) was the most common underlying reasons for BAV. Spearman correlation revealed that the mean pressure gradient reduction, determined by echocardiography, had a moderate correlation with the increase in the aortic valve area (AVA) in patients with NFHG AS (ρ: 0.529, p < .001) but showed no association in patients with LFLG (ρ: 0.017, p = .289) and pLFLG (ρ: 0.030, p = .889) AS. BAV as bridge to surgical or transcatheter aortic valve replacement was possible in 44.2% of patients, with no difference between groups (p = .070). CONCLUSION: The mean pressure gradient reduction might be an adequate surrogate parameter for BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities.

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis.

BACKGROUND: The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset. METHODS: Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria. RESULTS: Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm2 vs 0.70 cm2, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed. CONCLUSION: The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation.

Balloon Valvuloplasty Followed by Transcatheter Aortic Valve Implantation as a Staged Procedure in Patients With Low-Flow Low-Gradient Aortic Stenosis.

OBJECTIVE: Balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve implantation (TAVI) is a well-established treatment option in patients who are in a critical state or who suffer from underlying comorbidities that disguise the severity of aortic stenosis (AS). If convalescence is achieved, TAVI can be performed with good results in high-gradient aortic stenosis (HG-AS) patients. Whether this approach is safe and effective in low-flow low-gradient aortic stenosis (LFLG-AS) has not been analyzed; therefore, we investigated whether BAV followed by TAVI as a staged procedure is an effective treatment option in patients with LFLG-AS. METHODS: Patients with severe AS who received BAV followed by staged TAVI were identified. Baseline data, periprocedural and postprocedural information, echocardiographic data, and follow-up data were collected. The patient population was divided into LFLG-AS and HG-AS groups. RESULTS: From July 2009 until September 2017, we identified 38 eligible patients (16 LFLG-AS and 22 HG-AS). Log EuroScore I (51.8 ± 20.9% LFLG-AS vs 33.7 ± 19.1% HG-AS; P<.01) differed significantly between groups, as did baseline echocardiographic data that were used to categorize groups. BAV and staged TAVI were carried out 100% successfully with comparable results. Instant symptom relief and pressure gradient reduction were accomplished after both procedures. Thirty-day mortality rates (0% LFLG-AS vs 9% HG-AS; P=.21) and 1-year mortality rates (18.8% LFLG-AS vs 27.2% HG-AS; P=.54) did not differ between groups. CONCLUSION: BAV followed by staged TAVI is a safe and effective treatment option in sick or questionable candidates, irrespective whether LFLG-AS or HG-AS is present.

Dynamic coronary roadmapping during percutaneous coronary intervention: a feasibility study.

BACKGROUND: A novel software ("Dynamic Coronary Roadmap") was developed, which offers a real-time, dynamic overlay of the coronary tree on fluoroscopy. Once the roadmap has been automatically generated during angiography it can be used for navigation during percutaneous coronary interventions (PCI). As a feasibility study, we aimed to investigate the feasibility of real-time dynamic coronary roadmapping and consecutive coronary overlay during elective PCI. METHODS AND RESULTS: We studied 936 overlay runs, created following the same amount of angiographies, which were generated during 36 PCIs. Feasibility of dynamic coronary roadmapping was analyzed using a dedicated software tool. Roadmap quality (correct dynamic imaging of the vessels without relevant artefacts or missing parts) was distinguished from overlay quality (congruence of dynamic coronary roadmapping and coronary anatomy). Additionally, we assessed procedural success and the occurrence of major cardiac and cerebrovascular events (MACCE). Roadmap quality was defined as "fit for use" in 99.5%. In 97.4% of runs overlay quality was deemed "fit for use". Overall, we observed low inter and intra observer variability (ICC R = 0.84 for roadmap quality and R = 0.75 for overlay quality). Procedural success rate was 100%. MACCE occurred in two (5.6%) patients during post-interventional in-hospital stay and were not software-related. CONCLUSIONS: Dynamic coronary roadmapping provides in > 98% of cases sufficient roadmap quality with an anatomically correct overlay of the coronary vessels with good inter and intra observer variability. Future randomized studies are warranted to test possible advantages like procedure time reduction and less consumption of contrast medium.